Regional Anesthesia Morbidity Clinical Trial
Official title:
Effects of Ultrasound-guided Bilateral Suprazygomatic Maxillary Nerve Block on Postoperative Pain After Elective Bimaxillary Osteotomy in Adult Patients
Verified date | February 2020 |
Source | Servei Central d' Anestesiologia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Bimaxillary osteotomy is a surgery procedure of the orthognathic surgery field with the aim to correct dental and facial abnormalities, for both functional and aesthetic cases. The incidence of this abnormality is 5-10% of the population, and its etiology is unknown, with genetic, environmental and embryonic factors related. The surgical technique is complex, and requires osteotomy of the maxillary and jaw, which allows toward, forward, impact and rotation of these bones to fix the edges of the face. The anesthetic management of these patients is a challenge because of the difficult airway management and the perioperative pain control. Multimodal approach for pain control is a fact, and the use of local and regional anesthesia is mandatory. The investigators propose bilateral suprazygomatic maxillary nerve block for a proper control of postoperative pain after bimaxillary osteotomy.
Status | Completed |
Enrollment | 56 |
Est. completion date | January 30, 2020 |
Est. primary completion date | January 20, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - patients who undergo scheduled bimaxillary surgery Exclusion Criteria: - the refusal to participate in the study, - patients who are scheduled for bimaxillary surgery together with another complementary surgical procedure (such as mentoplasty, rhinoplasty, blepharoplasty), - age <18 years, - reinterventions, - urgent surgeries, - allergies to local anesthetics, - allergies to anti-inflammatories agents, - allergies to opioids, - American Society of Anesthesiologists Physical Status Classification (ASA) =3 |
Country | Name | City | State |
---|---|---|---|
Spain | Centro Medico Teknon - Grupo Quirón Salud | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Servei Central d' Anestesiologia |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Opioids consumption | evaluation of the effectiveness of the bilateral ultrasound-guided blockade with ropivacaine by suprazygomatic route, compared to the peripheral infiltration of the nerve with lidocaine and adrenaline, on the consumption of opioids for control of perioperative pain of patients intervened of elective bimaxillary osteotomy, evaluated by means of the analogical visual scale of pain in the immediate postoperative period (2 hours postoperatively). | 2hours postoperatively | |
Primary | comparison of the use of opioids in the intraoperative period | comparison of the use of opioids in the intraoperative period (Target Controlled Infusion (TCI) ng / ml - intravenous remifentanil), | intraoperatively | |
Secondary | comparison of the use of rescue opioids in the postoperative period in hospitalization | comparison of the use of rescue opioids (milligrams of intravenous methadone) in the postoperative period in hospitalization (2-18hours postoperative) | (2-18hours postoperative) | |
Secondary | the comparison of the incidence of immediate postoperative nausea and vomiting (PONV) | the comparison of the incidence of immediate postoperative nausea and vomiting (PONV) in resuscitation and up to 18 hours after surgery | 0-18hours after surgery | |
Secondary | registry of complications derived from ultrasound-guided maxillary nerve block. | registry of complications derived from ultrasound-guided maxillary nerve block. | 0-18hours after surgery |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT06005480 -
Understanding Rebound Pain After Regional Anesthesia Resolution in Healthy Volunteers
|
Phase 1 | |
Completed |
NCT04565093 -
Efficacy of iPACK After Unilateral TKA
|
N/A | |
Recruiting |
NCT06074471 -
Motor Sparing Supraclavicular Block
|
N/A | |
Completed |
NCT03740815 -
Feasibility of Serratus Plane Block Associated With Sedation in Axillary Dissection
|
N/A | |
Completed |
NCT02524652 -
Local Infiltration Analgesia vs Adductor Canal Block for Analgesia After Anterior Cruciate Ligament Reconstruction
|
Phase 4 | |
Completed |
NCT05012332 -
Local Anesthesia Spread After an Erector Spinae Plane Block.
|
N/A | |
Withdrawn |
NCT04015284 -
Intraoperative Pain and Quality of Surgical Block During Shoulder Surgery Assessed by NOL Index
|
N/A | |
Recruiting |
NCT05432934 -
Transversus Abdominis Plane Blocks With and Without Dexamethasone
|
Phase 1/Phase 2 | |
Recruiting |
NCT05512897 -
Does ESP Block Reduce Pain and Opiates Consumption After Surgery
|
N/A | |
Completed |
NCT04085263 -
Rhomboid Intercostal and Subserratus Plane Block
|
N/A | |
Not yet recruiting |
NCT04001387 -
Feasibility of Real-time Ultrasound-guided Spinal Anesthesia Using Dynamic Needle Tip Positioning
|
||
Active, not recruiting |
NCT05478629 -
Safety of Regional Anesthesia in Ukraine: the Survey
|
||
Terminated |
NCT03296033 -
Residual Anti-Xa Activity After Last Treatment Dose of Enoxaparin
|
Phase 4 | |
Withdrawn |
NCT02603900 -
Adductor Canal Catheter vs Local Infiltration of Analgesia for Total Knee Arthroplasty
|
Phase 4 | |
Completed |
NCT03666845 -
Plasma Ropivacaine Concentrations After Sciatic Nerve Block in Patients With Chronic Kidney Disease
|
||
Completed |
NCT03394807 -
LaGRA Trial in Laparoscopic Cholecystectomy
|
Phase 4 | |
Completed |
NCT05558449 -
Impact of Virtual Reality Hypno-sedation on Functional Recovery and Anxiety in Foot Surgery With Regional Anesthesia
|
Phase 4 | |
Completed |
NCT02433561 -
Intra- Versus Extraplexic Catheter Placement for Continuous Interscalene Brachial Plexus Block
|
Phase 4 | |
Recruiting |
NCT06147401 -
Comparison of PENG Associated With LFCN Block Versus FICB for Multimodal Analgesic Management in THA
|
N/A | |
Not yet recruiting |
NCT03805958 -
Ultrasound-guided Combined Spinal-epidural Anesthesia: Pre-procedure Versus Real-time Scan
|
N/A |